Assay precision, 99th percentile reference value and proportion of detected healthy european adults for VIDAS® high-sensitive troponin I

Abstract

Introduction/objectives: Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile. Methods: High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals. The capacity of detection on a healthy population of VIDAS® TNHS was validated on a total of 808 plasma samples. Results: One thousand six hundred and nineteen values (888 values for male samples and 731 values for female samples) were included in the analysis. The total imprecision of VIDAS® High-Sensitive Troponin I assay at the 99th percentile was 5.2 %, and 57.4 % of healthy individuals had troponin I values exceeding the LoD. Since the test detected more than 50 % of healthy individuals and had a coefficient of variation less than 10 % at the 99th percentile, it met the criteria of high-sensitivity cardiac troponin assays. Conclusion: VIDAS® High-Sensitive Troponin I assay is a high-sensitivity cardiac troponin assays meeting the definition provided by IFCC guidelines.

Keywords

• High-sensitivity
• Cardiac troponin I
• Healthy cohort
• Detection limits
• 99th percentile